Handheld Medical Diagnostic Devices With Sample Transfer

ABSTRACT

A lancet housing assembly for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is provided. The lancet housing assembly comprises an outer facing side and an inner facing side. An opening is located at the outer facing side that is arranged and configured to align with a lancet port of the medical diagnostic device. A floor extends between the outer facing side and the inner facing side and having a reagent material. A lancet structure having a skin penetrating end and a blood transport portion adjacent the skin penetrating end is located in housing assembly. The blood transport portion is arranged and configured receive the amount of blood from the skin penetrating end and to carry the amount of blood away from the skin site and to the reagent material.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of pending U.S. patentapplication Ser. No. 12/981,871, filed on Dec. 30, 2010, which is herebyincorporated in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to handheld medical devices,and in particular, to a handheld medical diagnostic device that canreduce steps needed to measure concentrations of biologicallysignificant components of bodily fluids.

BACKGROUND

Portable handheld medical diagnostic devices are often employed tomeasure concentrations of biologically significant components of bodilyfluids, such as, for example, glucose concentration in blood. Theportable handheld medical diagnostic devices and their accessories maywork together to measure the amount of glucose in blood and be used tomonitor blood glucose in one's home, healthcare facility or otherlocation, for example, by persons having diabetes or by a healthcareprofessional.

For people with diabetes, regular testing of blood glucose level can bean important part of diabetes management. Thus, it is desirable toprovide medical diagnostic devices that are portable and easy to use.Various medical diagnostic devices have been introduced for testingblood sugar that are portable. However, there continues to be a need forimproved portability and ease of use for medical diagnostic devices.

Often times, self-monitoring of blood glucose may require the patient tofirst load a lancet into a lancer and a separate test strip into a bloodglucose meter. The lancer and lancet are then used to prick the fingerand a small drop of blood is squeezed to the surface. The sample port onthe strip is brought into contact with the blood and the sample may betransported to the reaction zone on the strip. This can be alabor-intensive, uncomfortable process that requires multiple steps anddevices. Patients may need to repeat this process several times a day.

SUMMARY

In one embodiment, a lancet housing assembly comprising multiple lancetsfor use in a portable handheld medical diagnostic device for samplingbodily fluids from a skin site of a patient is provided. The lancethousing assembly includes a housing structure comprising multiple lancetcompartments. At least one of the lancet compartments comprises an outerfacing side and an inner facing side. An opening is located at the outerfacing side that is arranged and configured to align with a lancet portof the medical diagnostic device. A floor extends between the outerfacing side and the inner facing side. A reagent material is located onthe floor and within the lancet compartment. A lancet structure islocated in the at least one lancet compartment. The lancet structurecomprises a skin penetrating end and a blood transport portion adjacentthe skin penetrating end. The skin penetrating end, when extendedthrough the opening, is shaped and sized to penetrate the patient's skinat the skin site to provide an amount of blood. The blood transportportion is arranged and configured receive the amount of blood from theskin penetrating end and to carry the amount of blood away from the skinsite and to the reagent material.

In another embodiment, a portable handheld medical diagnostic device forsampling bodily fluids includes a protective enclosure. A measurementsystem includes a controller facilitating a physiologic measurement. Adisplay device is connected to the measurement system that displaysinformation related to the physiologic measurement. A housing structurecomprises multiple lancet compartments. At least one of the lancetcompartments includes an outer facing side and an inner facing side. Anopening is located at the outer facing side that is arranged andconfigured to align with a lancet port of the medical diagnostic device.A floor extends between the outer facing side and the inner facing side.A reagent material is located on the floor and within the lancetcompartment. A lancet structure is located in the at least one lancetcompartment. The lancet structure comprises a skin penetrating end and ablood transport portion adjacent the skin penetrating end. The skinpenetrating end, when extended through the opening, is shaped and sizedto penetrate the patient's skin at the skin site to provide an amount ofblood. The blood transport portion is arranged and configured receivethe amount of blood from the skin penetrating end and to carry theamount of blood away from the skin site and to the reagent material.

In another embodiment, a method of controlling movement of one or morelancet structures provided within a lancet housing assembly in aportable handheld medical diagnostic device for sampling bodily fluidsfrom a skin site of a patient is provided. The method includes locatinga lancet structure in at least one lancet compartment of the lancethousing assembly. The lancet structure includes a skin penetrating endand a blood transport portion adjacent the skin penetrating end. Theskin penetrating end is extended through a port of the medicaldiagnostic device and penetrating the patient's skin at the skin site toprovide an amount of blood. The amount of blood is received at the skinpenetrating end. The amount of blood is carried away from the skin siteusing the blood transport portion to the reagent material.

These and other advantages and features of the various embodiments ofthe invention disclosed herein, will be made more apparent from thedescription, drawings and claims that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of the exemplary embodiments of thepresent invention can be best understood when read in conjunction withthe following drawings, where like structure is indicated with likereference numerals, and in which:

FIG. 1 is a perspective view of an embodiment of a portable handheldmedical diagnostic device;

FIG. 2 is a schematic representation of the portable handheld medicaldiagnostic device of FIG. 1;

FIG. 3 is another perspective view of the portable handheld medicaldiagnostic device of FIG. 1 with an embodiment of a lancet housingassembly exposed;

FIG. 4 is a perspective view of the lancet housing assembly of FIG. 3 inisolation;

FIG. 5 is an exploded perspective view of the lancet housing assembly ofFIG. 3;

FIG. 6 is another exploded perspective view of the lancet housingassembly of FIG. 3;

FIG. 7 is an embodiment of a lancet compartment for use with the lancethousing assembly of FIG. 3 without a lancet structure;

FIG. 8 illustrates the lancet compartment of FIG. 7 with an embodimentof a lancet structure;

FIG. 9 illustrates the lancet compartment of FIG. 7 with the lancetstructure in operation;

FIG. 10 illustrates the lancet compartment of FIG. 7 with the lancetstructure in operation;

FIG. 11 illustrates the lancet compartment of FIG. 7 with the lancetstructure in operation;

FIG. 12 illustrates the lancet compartment of FIG. 7 with the lancetstructure in operation;

FIG. 13 illustrates the portable handheld medical diagnostic device ofFIG. 1 with a portion of the housing removed;

FIG. 14 is an exploded view of an embodiment of a spring-drive motor foruse in the portable handheld medical diagnostic device of FIG. 1;

FIG. 15 is a top view of an embodiment of a slidable cam housingassembly for use with the spring-drive motor of FIG. 14;

FIG. 16 illustrates the slidable cam housing assembly of FIG. 15 inoperation with the spring-drive motor of FIG. 14;

FIG. 17 illustrates the slidable cam housing assembly of FIG. 15 inoperation with the spring-drive motor of FIG. 14;

FIG. 18 illustrates the slidable cam housing assembly of FIG. 15 inoperation with the spring-drive motor of FIG. 14;

FIG. 19 illustrates the slidable cam housing assembly of FIG. 15 inoperation with the spring-drive motor of FIG. 14;

FIG. 20 illustrates the slidable cam housing assembly of FIG. 15 inoperation with the spring-drive motor of FIG. 14;

FIG. 21 illustrates the slidable cam housing assembly of FIG. 15 inoperation with the spring-drive motor of FIG. 14 and an embodiment of aspeed control mechanism;

FIG. 22 illustrates components of the speed control mechanism of FIG. 21in isolation;

FIG. 23 illustrates an example of a velocity control profile using thespeed control mechanism of FIG. 21;

FIG. 24 illustrates another embodiment of a lancet housing assembly;

FIG. 25 illustrates another embodiment of a lancet housing assembly;

FIG. 26 illustrates another embodiment of lancet housing assembly;

FIG. 27 illustrates the lancet housing assembly of FIG. 26 in operation;

FIG. 28 illustrates the lancet housing assembly of FIG. 26 in operation;

FIG. 29 illustrates another embodiment of lancet housing assembly;

FIG. 30 illustrates the lancet housing assembly of FIG. 29 in operation;

FIG. 31 illustrates the lancet housing assembly of FIG. 29 in operation;

FIG. 32 illustrates the lancet housing assembly of FIG. 29 in operation;

FIG. 33 illustrates the lancet housing assembly of FIG. 29 in operation;

FIG. 34 illustrates the lancet housing assembly of FIG. 29 in operation;

FIG. 35 illustrates the lancet housing assembly of FIG. 29 in operation;

FIG. 36 illustrates the lancet housing assembly of FIG. 29 in operation;

FIG. 37 illustrates the lancet housing assembly of FIG. 29 in operation;

FIG. 38 illustrates the lancet housing assembly of FIG. 29 in operation;

FIG. 39 illustrates the lancet housing assembly of FIG. 29 in operation;

FIG. 40 illustrates another embodiment of lancet housing assembly;

FIG. 41 illustrates the lancet housing assembly of FIG. 40 in operation;

FIG. 42 illustrates the lancet housing assembly of FIG. 40 in operation;

FIG. 43 illustrates the lancet housing assembly of FIG. 40 in operation;

FIG. 44 illustrates the lancet housing assembly of FIG. 40 in operation;

FIG. 45 illustrates the lancet housing assembly of FIG. 40 in operation;

FIG. 46 illustrates the lancet housing assembly of FIG. 40 in operation;and

FIG. 47 illustrates the lancet housing assembly of FIG. 40 in operation.

DETAILED DESCRIPTION

The following description of the preferred embodiment is merelyexemplary in nature and is in no way intended to limit the invention orits application or uses.

Embodiments described herein generally relate to handheld medicaldiagnostic devices that are used to acquire and measure concentrationsof biologically significant components of bodily fluids. In particular,the handheld medical diagnostic device may be used to acquire a bloodsample and measure a blood glucose level of the sample. As will bedescribed below, the medical diagnostic device may include amotor-driven lancet structure inside the medical diagnostic device,which can be used to generate a prick wound in a body part. The lancetstructure can also be used to take up blood emerging from the prickwound using capillary action and deliver the blood to a reagentmaterial. A measuring system located in the medical diagnostic devicemay be used to determine a blood glucose concentration value of theacquired blood.

Referring to FIG. 1, a portable, handheld medical diagnostic device 10with a display device 12 behind a transparent, protective lens 13includes a protective enclosure, generally indicated by element 14 thatprotects electronics and other mechanical components therein. Theprotective enclosure 14 is somewhat rectangular in shape, however, anyother suitable shapes may be used for the protective enclosure, such ascircular shapes, etc. The display device 12 may be any suitable displaydevice used in a portable, handheld electronic device, such as, forexample, but not limited to LCD display devices, LED display devices,OLED display devices, and other types of display devices which may beheretofore developed. Further, display device 12 may be any othervariety of indicators, including, but not limited to a series of lightsand/or other types of light devices as opposed to a single integrateddisplay screen. In the illustrated embodiment, the display device 12includes an electronic paper component such as an electrophoreticdisplay, which may be an information display that forms visible imagesby rearranging charged pigment particles using an electric field. Thedisplay device 12 may be used for electronically displaying graphics,text, and other elements to a user. In some embodiments, the displaydevice 12 may be a touch-screen user interface that is used with the tipof a finger of the user and/or a stylus or other touching device toselect elements from the screen, to draw figures, and to enter text witha character recognition program running on the device 10. In someembodiments, the medical diagnostic device 10 may also include othertypes of output devices such as for example, sound devices, vibrationdevices, etc.

The medical diagnostic device 10 further includes a user interface(generally referred to as element 17), which may include buttons 15, 16and 18. The buttons 15, 16 and 18 may be used by an operator, forexample, to view memory of the medical diagnostic device 10, adjustsettings of the device and scroll through test results. The buttons 15,16 and 18 may be manually actuated, such as by pressing the buttons. Thebuttons 15, 16 and 18 may comprise touch sensors (e.g., resistive orcapacitive touch sensors, surface acoustic wave sensors, infrared LED,photodetectors, piezoelectric transducers, etc.) that can be actuated byplacing and/or pressing a tip of the finger within the button areas. Inthese embodiments, the buttons 15, 16 and 18 may not move. Instead, thebuttons 15, 16 and 18 may be indicated visually to identify where toplace the finger. In other embodiments utilizing touch sensors, thebuttons 15, 16 and 18 may move, for example, to bring the finger ortouching device into close proximity to the touch sensor. In someembodiments, the medical diagnostic device 10 may provide other buttonor input types such as an OK button and/or joy stick/track ball, which auser may utilize to navigate through a software drive menu provided onthe display device 12. Additional buttons may be used as shortcutbuttons, for example, to call up a certain program on the medicaldiagnostic device 10, as a method of scrolling, to select items from alist, or to provide any function that the software designer of thedevice may assign to the button or set of buttons. Each button size,layout, location, and function may vary for each manufacturer and modelof the medical diagnostic device 10.

A lancet port 20 is located at a bottom 22 of the medical diagnosticdevice 10. The lancet port 20 provides an opening through which thelancet structure can extend outwardly from the protective enclosure 14.The lancet structure may extend outwardly from the lancet port 20 tomake an incision at a skin site of the patient and produce an amount ofbodily fluid from the skin site of the patient. In one embodiment, themedical diagnostic device 10 is an in vitro diagnostic device that isused to test blood and other body fluids and tissues to obtaininformation for the diagnosis, prevention and treatment of a disease.The medical diagnostic device 10 may be a self-testing blood glucosemeter for people with diabetes. In one embodiment, the medicaldiagnostic device 10 is a handheld reagent-based blood glucose meter,which measures glucose concentration by observing some aspect of achemical reaction between a reagent and the glucose in a fluid sample.The reagent may be a chemical compound that is known to react withglucose in a predictable manner, enabling the monitor to determine theconcentration of glucose in the sample. For example, the medicaldiagnostic device 10 may be configured to measure a voltage or a currentgenerated by the reaction between the glucose and the reagent in oneembodiment, electrical resistance in another embodiment, as well as acolor change of the reagent in still another embodiment.

In some embodiments, the medical diagnostic device 10 is amechanically-driven device where the protective enclosure 14 includes awinding assembly (not shown) that is operated using telescoping housingportions 25 and 27. FIG. 1 illustrates the telescoping housing portions25 and 27 in their initial, uncocked positions. As will be described ingreater detail below, the housing portions 25 and 27 may be movedrelative to each other manually to place a lancet actuator assembly (notshown) in a wound, triggerable configuration. The lancet actuatorassembly may be used to drive a lancet structure through the lancet port20 to make an incision at a skin site of the patient and produce anamount of bodily fluid that can then be carried from the skin site ofthe patient. In some embodiments, the housing portion 27 includes acartridge housing 29 with a removable door 31 for holding a lancethousing assembly (not shown) that includes multiple lancet structures.In other embodiments, the door 31 may be hinged to the housing portion27, such that it can be rotated relative to the housing portion 27 topermit access to the cartridge housing 29 for removing or loading thelancet housing assembly. An indicator device 33 may be provided thatprovides the patient with information regarding the number of unusedlancet structures available in the lancet housing assembly. In thisembodiment, the indicator device 33 includes a window 35 in theremovable door 31 that allows viewing of numbers provided on the lancethousing assembly as the lancet housing assembly is indexed within thecartridge housing 29.

Referring to FIG. 2, a simplified, schematic view of the medicaldiagnostic device 10 includes a number of features that allow forimproved comfort and ease of use for a patient. In general, the medicaldiagnostic device 10 may include a lancet housing assembly 30 in theform of a cartridge or disk that is used to house multiple lancetstructures 24 for use in the medical diagnostic device 10, a lancetactuator assembly 28 for extending and/or retracting the lancetstructures 24 and a speed control mechanism 36 that engages the lancetactuator assembly 28 for adjusting the speed at which the lancetstructure 24 is extended and/or retracted by the lancet actuatorassembly 28. A depth adjustment mechanism 37 may also be provided thatallows for adjustment of a penetration depth of the lancet structure 24before extending the lancet structure 24.

A measurement system 32 may be provided that measures glucoseconcentration in a blood sample delivered to a test material 39, forexample, using an optical device 34 in one embodiment for detecting acolor change in a reagent or other suitable device in other embodiments,such as electrical contacts if measuring a change in an electricalcharacteristic/property of the reagent. The test material 39 may beemployed to hold the reagent and to host the reaction between theglucose and the reagent mentioned above. In one embodiment, the testmaterial 39 and the optical device 34 may be located such that thereaction between the glucose and the reagent may be read electronicallyin order for the measurement system 32 to determine the concentration ofglucose in the sample and display the results to a user using thedisplay device 12. These embodiments enable both health careprofessionals and patients to perform reliable decentralized testing inhospitals, clinics, offices or patients' homes.

Referring to FIGS. 3-6, in some embodiments, multiple lancet structuresare housed in the lancet housing assembly in the form of a disk 30 thatincludes multiple lancet compartments 40 (FIG. 5) arranged in a radialfashion about a central axis 42. The disk 30 may have an outerprotective housing (not shown) formed of any one or more suitablematerials, such as plastics, foils, metals, and the like. Materials withsterile moisture barriers may be used to provide lancet compartments 40with protected environments. In some embodiments, such as the oneillustrated, the disk 30 may be formed by a center hub 48 and a diskcomponent 51 that is configured to rotate relative to the center hub 48.In some embodiments, the disk component 51 includes an upper disk member41 and a lower disk member 43 that is connected to the upper disk member41. Any suitable connection may be used between the upper and lower diskmembers 41 and 43, such as laser welding, snap fit, press fit,adhesives, fasteners, and the likes.

As depicted in the exploded view of FIG. 5, the center hub 48 may beprovided within a central bore 50 of the disk 30 such that it may rotaterelative to the disk component 51. In one embodiment, the center hub 48may be provided such that it may snap fit into place within the centralbore 50 of the disk 30. For example, the center hub 48 may includefastening structures 47 in the form of hook-like projections that engagea bottom surface 73 of the disk component 51. Although the center hub 48may be mounted rotatably within the central bore 50 of the disk 30 suchthat it may be removably retained therein, such as via the snap fitarrangement depicted in FIG. 5, or via a fastener(s) in anotherembodiment which provides a nut or clip (not shown) which engages athreaded or shaped end (not shown) of the center hub 48 adjacent thebottom surface 73, in other embodiments the center hub 48 may beprovided rotatably therein but also retained permanently therein, suchas via laser welding in another embodiment which provides a deformedfree end (not shown) of the center hub 48 that flairs outwardly aboutthe bottom surface 73. The center hub 48 may have a non-circular orirregular-shaped (e.g., D-shaped) key or opening 75 that allows forautomatic alignment of the disk 30 in only one or more orientations forinsertion into a disk compartment 52 of the medical diagnostic device10. For example, in the illustrated embodiment, the D-shaped key mayallow for automatic alignment of the disk 30 in only one orientation forinsertion into the disk compartment 52.

In addition to FIG. 5, FIG. 6 also illustrates an exploded view of thedisk 30 including the upper disk member 41 and the lower disk member 43of the disk component 51 and the center hub 48. The upper disk member 41includes a top surface 49 and a bottom surface 56 opposite the topsurface 49. Numbered indicia 53 (FIG. 5) may be printed, molded, etched,machined, etc. onto the top surface 49 for providing the user anindication of the number of unused lancet structures 24 are remaining orhave been used. The numbered indicia 53 may be viewed through the window35 of the removable door 31 (FIG. 1). Notches 55 extend inwardly fromthe top surface 49 of the upper disk member 41. The notches 55 arespaced angularly from adjacent notches 55 and are located substantiallyequidistant from the center of the upper disk member 41. The notches 55may each be associated with a respective lancet compartment 40 andprovide engagement structure for preventing over rotation of the disk 30relative to the center hub 48.

The center hub 48 may include rotation limiting structure 54 thatcooperates with rotation limiting structure (e.g., the notches 55) ofthe upper disk member 41. The center hub 48 may include arm members 57and 59, each having a downward protruding projection 61 and 63 that issized and arranged to be removably received by the notches 55 as theupper disk member 41 rotates relative to the center hub 48. Theprojections 61 and 63 may each include a relatively vertically orientedside 65 and a relatively angled side 67 that is at an angle to thevertical. The vertically oriented side 65 can inhibit rotation of theupper disk member 41 relative to the center hub 48 while the angled side67 allows rotation of the upper disk member 41 relative to the centerhub 48 in the opposite direction. The arm members 57 and 59 may beformed of a somewhat flexible material to allow the arm members 57 and59 to resiliently bend so that the projections 61 and 63 may move out ofone notch 55 and be received by an adjacent notch 55 for locking theupper disk member 41 in an angular relationship relative to the centerhub 48. Cooperating end stops 58 and 69 may also be provided to preventrotation of the upper disk member 41 relative to the center hub 48 oncethe end stops 58 and 69 engage.

The lower disk member 43 includes a top surface 79, a bottom surface 73opposite the top surface 79, an outer facing side 64 and an inner facingside 66. The lancet compartments 40 extend in a generally radialdirection from the inner facing side 66 to the outer facing side 64. Thelancet compartments 40 may be equally spaced an angular distance apartfrom one another and about the periphery of the lower disk member 43. Aswill be described in greater detail below, each lancet compartment 40may include a lancet structure 24 that can extend through an opening 68in each lancet compartment 40 and through the lancet port 20 of themedical diagnostic device 10. Extending downwardly from the bottomsurface 73 of the lower disk member 43 are indexing pins 77. Theindexing pins 77 may be used to rotate the disk component 51 relative tothe center hub 48, for example, after each operation of the lancetstructures 24.

Referring to FIGS. 7 and 8, an exemplary empty lancet compartment 40 anda lancet compartment 40 with an unused lancet structure 24 are shown,respectively. Referring first to FIG. 7, the lancet compartment 40 isformed, in part, by a compartment section 62 of the lower disk member43. The upper disk member 41 is removed in FIGS. 7 and 8 for clarity.The compartment section 62 includes the outer facing side 64 and theinner facing side 66. The opening 68 is located at the outer facing side64 that can align with the lancet port 20 located at the bottom 22 ofthe medical diagnostic device 10 (FIG. 1). Sidewalls 78 and 80 extendbetween the outer facing side 64 and the inner facing side 66. Aclearance floor 70 extends from an inner wall 71 at the outer facingside 64 within the lancet compartment 40 to the inner facing side 66 andforms a lowermost floor of the lancet compartment 40. Adjacent the innerwall 71 of the lancet compartment 40 is a reagent material 72, which islocated on the clearance floor 70 and within the lancet compartment 40.The reagent material 72 may be a test strip such as electrochemical typetest strips, colorimetric or optical type test strips, etc. to name afew.

Drop down slots 74 and 76 are located in sidewalls 78 and 80 and extendvertically from the top surface 79 of the compartment section 62 to alancet floor 84. Another drop down slot 75 is located in the inner wall71 and extends vertically from the opening 68 to the reagent material72. The lancet floor 84 extends along the clearance floor 70, in araised relationship thereto, from the reagent material 72 back towardthe inner facing side 66 and within the drop down slots 74 and 76. Insome embodiments, the lancet floor 84 may be formed by a pair of strips85 and 87 that extend along their respective sidewall 78 and 80 andspaced-apart from each other thereby exposing part of the clearancefloor 70 therebetween. In some embodiments, the lancet floor 84 and theclearance floor 70 may both be part of the same floor structure. Thelancet floor 84 provides clearance between the clearance floor 70 andthe lancet structure 24 when the lancet structure is dropped downagainst the reagent material 72 and seated against the lancet floor 84.Lancet guide rails 86 and 88 extend along the sidewalls 78 and 80 andrecessed vertically below the top surface 79 of the compartment section62. In some embodiments, the lancet guide rails 86 and 88 extendsubstantially parallel to the lancet floor 84 and/or clearance floor 70from the drop down slots 74 and 76 to the opening 68 with the drop downslot 75 intersecting the lancet guide rails 86 and 88 at the inner wall71 and the drop down slots 74 and 76 intersecting the guide rails 86 and88, respectively, at the sidewalls 78 and 80.

Referring to FIG. 8, the lancet compartment 40 is illustrated with alancet structure 24. The lancet structure 24, in this exemplaryembodiment, includes a skin penetrating end 90 and a blood transportportion 92 adjacent the skin penetrating end 90. In some embodiments,the blood transport portion 92 may include one or more capillarystructures that facilitate movement of the bodily fluid away from theskin penetrating end to the blood transport portion 92. The skinpenetrating end 90, when extended through the opening 68, is shaped andsized to penetrate the patient's skin at a skin location in order toprovide an amount of blood. The blood transport portion 92 can receivethe amount of blood from the skin penetrating end 90 and be used tocarry the amount of blood away from the skin location.

A drive member connecting structure 94 is located at an end 96 that isopposite the skin penetrating end 90. In this embodiment, the drivemember connecting structure 94 is a closed opening 98 having a rearledge 100 that is used to engage the drive member 95 (e.g., in the formof a drive hook). Rail riding structure in the form of outwardlyextending wings 102 and 104 are located between the drive connectingstructure 94 and the blood transport portion 92. The wings 102 and 104extend outwardly in the widthwise direction to ride along the lancetguide rails 86 and 88 when extending and retracting the lancet structure24.

Referring to FIG. 9, a cross-section of the lancet compartment 40 isillustrated in an assembled configuration with the upper disk member 41connected to the lower disk member 43 thereby providing the lancetcompartment 40 therebetween. The drive member 95 extends into the lancetcompartment 40 and is illustrated releasably engaged with the drivemember connecting structure 94 of the lancet structure 24. The skinpenetrating end 90 of the lancet structure 24 is illustrated as restingon a bottom surface 106 of the opening 68 while the wings (only wing 102is partially shown) rest on the lancet guide rails (only guide rail 86is partially shown).

A biasing mechanism 108 (e.g., a flat spring) extends into the lancetcompartment 40, toward the lancet floor 84 and engages a surface 110 ofthe lancet structure 24. The biasing mechanism 108 may be connected atopposite ends 112 and 114 to a ceiling 116 of the upper disk member 41.A projection 118 formed in the biasing mechanism 108 may be providedthat mates with a corresponding detent 120 of the lancet structure 24(FIG. 8). In another embodiment, the lancet structure 24 may include theprojection 118 and the biasing mechanism 108 may include the detent 120.Any other suitable mating arrangement can be used, such as opposing rampstructures. This mating arrangement can provide added resistance tounintended movement of the of the skin penetrating end 90 of the lancetstructure 24 through the opening 68.

Referring to FIG. 10, the lancet structure 24 may be extended throughthe opening 68 in the direction of arrow 122 using the drive member 95that is connected to the drive member connecting structure 94. As can beseen by FIGS. 9 and 10, the biasing mechanism 108 may include a slot 124that is formed along a length of the biasing mechanism 108, between theends 112 and 114. The slot 124 may be sized to receive a hook portion126 of the drive member 95 and to allow movement of the drive member 95through the slot 124 and toward the opening 68. In some embodiments, thehook portion 126 of the drive member 95 is received within the slot 124such that the biasing mechanism 108 maintains contact with the lancetstructure 24 as the lancet structure 24 is being driven toward theopening 68. As the lancet structure 24 is driven toward the opening 68,the outwardly extending wings 102 and 104 ride along the lancet guiderails 86 and 88 of the sidewalls 78 and 80.

Referring to FIG. 11, the lancet structure 24 may be retracted from theopening 68 in the direction of arrow 128 using the drive member 95. Thehook portion 126 of the drive member 95 may be received within the slot124 such that the biasing mechanism 108 maintains contact with thelancet structure 24 as the lancet structure 24 is being driven away fromthe opening 68. As shown in FIG. 11, once the outwardly extending wings102 and 104 that ride along the lancet guide rails 86 and 88 of thesidewalls 78 and 80 align with the drop down slots 74 and 76, and theskin penetrating end 90 aligns with or moves beyond the drop down slot75, the biasing mechanism 108 forces the lancet structure 24 in adirection substantially transverse to the retract direction 128, towardthe lancet floor 84 and the reagent material 72. Thus, the biasingmechanism 108 can be used to automatically deliver the lancet structure24 to the reagent material 72 as the lancet structure 24 is retracted bythe drive member 95.

Referring to FIG. 12, the lancet structure 24 is illustrated fullyretracted and directed toward the reagent material 72. In this position,the skin penetrating end 90 and the blood transport portion 92 of thelancet structure 24 are offset from the opening 68 (i.e., out ofalignment with the opening 68) and in contact with the reagent material72 such that blood can be transferred to the reagent material 72. Inaddition to delivering the lancet structure 24 to the reagent material72, the offset arrangement of the skin penetrating end 90out-of-alignment with the opening 68 can also inhibit unintendedextension of the skin penetrating end 90 through the opening 68 by thedrive member 95, which no longer can engage and extend the lancetstructure 24. In particular, in the illustrated embodiment should thedrive member 95 once again move towards the opening 68 of the lancetcompartment 40 containing a used lancet structure 24, the drive member95 will pass over the lancet structure 24 due to the offset arrangementalso placing the drive member connecting structure 94 of the lancetstructure 24 out-of-alignment with drive member 95. Accordingly, thebiasing mechanism 108 providing the lancet structure 24 in the offsetarrangement after the transfer of blood from the blood transport portion92 of the lancet structure 24 to the reagent material 72, provides aconvenient fail safe.

Referring to FIG. 13, the drive member 95 including the hook portion 126is operatively connected to the lancet actuator assembly 28, which isused to extend and retract the drive member 95. The drive member 95 isconnected to a hook arm 130. The hook arm 130 can slide along a pair ofguide rails 132 and 134, which are used to accurately guide the drivemember 95 toward extended and retracted positions. The guide rails 132and 134 are fixedly connected to the housing portion 27 by an anchor136. The hook arm 130 is connected to a follower arm 138 by anadjustable linkage 140. The follower arm 138 is driven in oppositedirections (represented by arrows 142) by a clockwork spring driveassembly 144, which, in turn, moves the hook arm 130 and drive member 95between their extended and retracted positions.

A rack member 146 is used to wind the clockwork spring drive assembly144 and includes a rack portion 148 and a disk indexing portion 150. Therack portion 148 includes a first bar 152 having teeth 154 along itslength and a second bar 156 having no teeth that is spaced from thefirst bar 152 by a slot 158. The teeth 154 are meshed with teeth 160 ofa cam gear 162 having arms 164 and 166 that can engage a spring wheelassembly 168 (e.g., when rotating in only one direction, such asclockwise) for rotating the spring wheel assembly 168.

The rack member 146 may also include an indexing component 147 that isused to engage the indexing pins 77 of the disk 30. The indexingcomponent 147 may include a pin engagement structure 149 including aramp portion 151. As the rack member 146 is moved backward, the rampportion 151 may engage one of the indexing pins 77, forcing the diskcomponent 51 to rotate relative to the center hub 48.

The rack member 146 is connected to a slidable cam housing assembly 170(e.g., using a pair of pins 172 and 174 or any other suitableconnection). The slidable cam housing assembly 170 is connected to thetelescoping housing portion 25 (e.g., using fasteners 175) such thatmovement of the telescoping housing portion 25 relative to thetelescoping portion 27 moves the rack member 146 relative to theclockwork spring drive assembly 144. As can be appreciated from FIG. 13and from the description below, movement of the rack member 146 in thedirection of arrow 176 causes the cam gear 162 to rotate in thecounterclockwise direction. Rotating counterclockwise, the cam gear 162may not engage the spring wheel assembly 168 and may rotate relativethereto. Thus, moving the telescoping portion 27 outwardly in thedirection of arrow 176 places the rack member 146 in a preload orpre-primed position that is ready to wind or prime the clockwork springdrive assembly 144 during its return stroke. Movement of the rack member146 in a direction opposite arrow 176 causes the cam gear 162 to rotatein the clockwise direction. Rotating clockwise, the cam gear 162 engagesthe spring wheel assembly 168 thereby rotating the spring wheel assembly168 in the clockwise direction, which can wind the clockwork springdrive assembly 144, as will be described in greater detail below.

FIG. 14 illustrates an exploded view of the exemplary clockwork springdrive assembly 144 in isolation. The clockwork spring drive assembly 144includes the cam gear 162 and the spring wheel assembly 168. The springwheel assembly 168 includes a spring wheel 180, a torsion spring 182, acover plate 184 and a roller wheel 186. The spring 182 connects thespring wheel 180 to the roller wheel 186 with the cover plate 184providing a smooth, relatively low friction surface between the spring182 and the roller wheel 186. At an inner end 188, the spring 182 isconnected to the roller wheel 186, while at an outer end 190, the spring182 is connected to the spring wheel 180. Rotation of the spring wheel180 relative to the roller wheel 186 about a pivot axle 187 causes thespring 182 to wind thereby increasing the stored energy in the spring182.

The roller wheel 186 includes a face cam portion 192 including a groove196 that is provided at a face 198 of the roller wheel 186. The groove196 provides a track that is followed by the follower arm 138 (FIG. 13)such that the follower arm 138 is moved a fixed distance betweenextended and retracted positions as the roller wheel 186 rotates. Afollower pin 200 is provided at an opposite face 202 of the roller wheel186. Rotation of the roller wheel 186 (and thus movement of the followerarm) is controlled through interaction between the follower pin 200 anda cam track portion of the slidable cam housing assembly 170.

Referring to FIG. 15, the slidable cam housing assembly 170 is depictedin isolation and includes a first side member 204, a second side member206 and an end member 208 that extends between the first and second sidemembers 204 and 206 thereby forming a somewhat U-shape. At each firstand second side member 204 and 206 is a respective slidable rail 207,209 that, in the illustrated embodiment, have a U-shaped groove 210 forslidably receiving a rail 212 of the housing portion 27 (FIG. 13)thereby forming a slide/rail assembly. The end member 208 includes thepins 172 and 174 for connecting the rack member 146 thereto and springhousing structures 214, 216 and 218, each for receiving a coil spring.

A track portion 220 extends outwardly from the end member 208 andgenerally between the first and second side members 204 and 206. Thetrack portion 220 is formed by a pair of track support members 222 and224 that are cantilevered at one end 226 and 228 to the end member 208and extend outwardly to a joined free end 330. A slot 332 extends alonga length of the track portion 220 that is sized to receive the pivotaxle 187 of the clockwork spring drive assembly 144 such that theslidable cam housing assembly 170 can slide by the pivot axle 187.Carried by each of the track support members 222 and 224 is a respectiveelongated guide track element 225 and 227 that extends upwardly from topsurfaces 229 and 231 of each track support member 222 and 224. The guidetrack elements 225 and 227 are used to control winding and releasing ofthe clockwork spring drive assembly 144 by controlling (i.e., allowingand disallowing) rotation of the roller wheel 186.

FIGS. 16-20 illustrate a priming and firing sequence utilizing theclockwork spring drive assembly 144 and the slidable cam housingassembly 170. The roller wheel 186 is shown somewhat transparent suchthat the follower pin 200 can be seen as it interacts with the trackportion 220 and the guide track elements 225 and 227. FIG. 16illustrates the roller wheel 186 and the slidable cam housing assembly170 in a start position with the follower pin 200 biased clockwiseagainst a wall portion 334 of the guide track element 225 by the spring182. In this position, the slidable cam housing assembly 170 can bepulled in the direction of arrow 336 relative to the clockwork springdrive assembly 144 through the connection of the slidable cam housingassembly 170 with the housing portion 25 and due to the clockwork springdrive assembly 144 being rotatably connected to the housing portion 27.FIG. 17 illustrates the slidable cam housing assembly 170 in a fullypre-primed position with the follower pin 200 biased against a wallportion 338 of the guide track element 227. As indicated above, movementof slidable cam housing assembly 170 and the rack member 146 connectedthereto (FIG. 13) in the direction of arrow 336 causes the cam gear 162to rotate in the counterclockwise direction. Rotating counterclockwise,the cam gear 162 may not engage the spring wheel assembly 168 and mayrotate relative thereto without winding the spring 182. However, thespring 182 may be preloaded an amount such that the follower pin 200moves against the guide track element 225, over an edge 340 of the guidetrack element 225 and to the wall portion 338 of the guide track element227 in the fully pre-primed position.

Referring now to FIG. 18, the slidable cam housing assembly 170 may bepushed in the direction of arrow 342 toward a wound, triggerableposition (or primed position) once placed in the fully pre-primedposition with the follower pin between the guide track elements 225 and227. As the slidable cam housing assembly 170 is pushed in the directionof arrow 342, the movement of slidable cam housing assembly 170 and therack member 146 connected thereto (FIG. 13) in the direction of arrow342 causes the cam gear 162 to rotate in the clockwise direction.Rotating clockwise, the cam gear 162 engages the spring wheel assembly168 thereby rotating the spring wheel assembly 168 and winding thespring 182. The guide track element 227 prevents rotation of the rollerwheel 186, which allows the spring 182 to wind relative to the rollerwheel 186 as the spring wheel assembly 168 rotates.

The follower pin 200 follows along the guide track element 227 until thefollower pin 200 reaches an opening 344. The follower pin 200 may thenbe rotated into the opening 344 due to the bias force provided on theroller wheel 186 by the spring 182. With the follower pin 200 in thisposition, the slidable cam housing assembly 170 is in a primed,safety-ready position. Biasing members 346, 348 and 350 (e.g., coilsprings) may be provided that provide a slight spring back force oncethe slidable cam housing assembly 170 in the primed, safety-readyposition shown by FIG. 18. The slight spring back force causes theslidable cam housing assembly 170 to move a relatively short distance inthe pull direction of arrow 336, which allows the follower pin 200 torotate around an edge 352 of the guide track element 227 and into thewound, triggerable position illustrated by FIG. 19.

Once the follower pin 200 is in the wound, triggerable position of FIG.19, the medical diagnostic device 10 is ready to fire the lancetstructure 24 through the lancet port 20. Triggering the medicaldiagnostic device 10 may be accomplished by placing the finger or otherbody part on the lancet port 20, pushing the housing portion 25 towardthe housing portion 27 and overcoming the bias provided by the biasingmembers 346, 348 and 350. Referring to FIG. 20, the roller wheel 186rotates due to the bias provided by the spring 182 once the follower pin200 moves beyond a release point 354 provided by the guide track element227. Rotation of the roller wheel 186 causes the lancet structure 24 toextend outwardly from the lancet port 20 and retract back into thelancet port 20.

In some embodiments, a velocity profile of the lancet structure 24 whenbeing extended and retracted using the clockwork spring drive assembly144 may be controlled such that the velocity profile is asymmetricduring the extending and retracting phases. Such control can affectimpact, retraction velocity and dwell time of the skin penetrating end90 of the lancet structure 24.

Referring again to FIG. 13 and also to FIG. 21, the speed controlmechanism 36 may be a gearbox and includes a housing 356 including a topwall 358, a bottom wall 360 and sidewalls 362. Located at leastpartially in the housing are gears 364, 366, 368 and 370. Referring alsoto FIG. 22, the gear 364 is an engagement gear and engages the clockworkspring drive assembly 144 as the roller wheel 186 rotates. In oneembodiment, the roller wheel 186 includes an eccentric ring member 372(e.g., formed of rubber or plastic) that increases the diameter of theroller wheel 186 at a particular location at the periphery of the rollerwheel 186. As the roller wheel 186 rotates during the return stroke ofthe lancet structure 24, the eccentric ring member 372 engages the gear364 thereby rotating the gear 364 and slowing the roller wheel 186. Asthe gear 364 rotates, it causes the gears 366, 368 and 370 to rotate.Gear 370 includes a flywheel 374 with weights 376 that are selected tomechanically slow the roller wheel 186 a selected amount. In someembodiments, the gear ratio provided by the gears 364, 366, 368 and 370may be about 18:1 and the mass of the flywheel 374 may be less than onegram, such as about 0.67 gram.

Referring to FIG. 23, an exemplary velocity over time profile of thelancet structure 24 is illustrated. As can be seen, portion A showsrelatively rapid acceleration of the lancet structure 24 as the skinpenetrating end 90 approaches and penetrates a skin cite. Portion Bshows relatively slow deceleration of the lancet structure 24 as theskin penetrating end exits the skin cite. In some embodiments, a ratioof time during the extending phase to time during the retracting phaseis at least about 1:25. Deceleration is adjustable by, for example,adding mass to the flywheel 351 and/or by changing the gear ratio.

Referring again to FIG. 13, as noted above, the medical diagnosticdevice 10 may further include the depth adjustment mechanism 37. Thedepth adjustment mechanism 37 may include a thumb wheel 355 that isadjustably connected to the adjustable linkage 140 at a pivot locationP₁. Rotation of the thumb wheel 355 causes movement of an end 357 of theadjustable linkage 140, which, in turn, causes the adjustable linkage topivot about pivot location P₂ and adjusts the start position of the hookportion 126 of the drive member 95. Movement of the hook portion 126 ofthe drive member 95 toward the lancet port 20 can increase thepenetration depth of the skin penetrating end 90 of the lancet structure24 due to the fixed stroke length of the follower arm 138 and rollerwheel 186. Movement of the hook portion 126 of the drive member 95 awayfrom the lancet port 20 can decrease the penetration depth of the skinpenetrating end 90 of the lancet structure 24. As one exemplaryembodiment, the penetration depth (e.g., the distance the skinpenetrating end 90 extends beyond the lancet port 20) may be adjustablefrom about 0.8 mm to about 2.3 mm. Additionally, because the followerarm 138 is connected to the adjustable linkage 140 (e.g., at slot 381)for extending and retracting the drive member 95, the adjustable linkage140 may act to amplify movement of the drive member 95 relative tomovement of the follower arm 138. In some embodiments, the adjustablelinkage 140 provides a multiplier of 1.8:1 ratio of the drive member 95to the follower arm 138.

Referring now to FIG. 24, an alternative embodiment of a lancet housingassembly 400 (e.g., in the form of a disk) includes an upper disk member402 and a lower disk member 404 defining a lancet compartment 405. Alancet structure 406 includes a skin penetrating end 408, a bloodtransfer portion 410 and engagement structure 412 for engaging a drivemember 414. Similar to the embodiments described above, the lancetstructure 406 includes a laterally extending wing 416 that can ridealong a side rail 418 extending along a side wall 420 of the lancetcompartment 405. In this embodiment, the side rail 418 includes a step422 that causes the lancet structure 406 to move (i.e., snap down)toward a lancet floor 424, release the driver member and bring the skinpenetrating end 408 in contact with a reagent material 426. In theillustrated embodiment, the step 422 is substantially parallel tovertical (i.e., perpendicular to the side rail 418), however, the stepmay be at other angles to vertical.

Referring to FIG. 25, another embodiment of a lancet housing assembly430 may utilize a curvature of a lancet structure 432 to bring a skinpenetrating end 434 of the lancet structure 432 in contact with areagent material 436. In this embodiment, the lancet structure 432includes a laterally extending wing 438 that can ride along a curvedside rail 440 extending along a side wall 442 of the lancet compartment444. When the skin penetrating end 434 is pulled by the opening 446, thecurvature of the lancet structure 432 causes the skin penetrating end434 to come into contact with the reagent material 436.

Referring to FIGS. 26-28, movement of a lancet structure 450 may have alateral or sideways component (i.e., angular movement toward an adjacentlancet compartment). A lancet housing assembly 452 (e.g., in the form ofa disk) includes an upper disk member 454 and a lower disk member 456defining the lancet compartment 458. The lancet structure 450 includes askin penetrating end 462, a blood transfer portion 464 and engagementstructure 466 for engaging a drive member. Similar to the embodimentsdescribed above, the lancet structure 450 includes a laterally extendingwing 468 that can ride along a side rail 470 extending along a side wall472 of the lancet compartment 458. In this embodiment, the opening 474includes a horizontal wall component 476 that forces the skinpenetrating end 462 laterally toward an adjacent lancet compartment tobring the lancet structure 450 into contact with an reagent material478.

FIGS. 29-41 illustrate another embodiment of a lancet housing assembly500 including an upper disk member 502 and a lower disk member 504defining a lancet compartment 505. A lancet structure 506 includes askin penetrating end 508, a blood transfer portion 510 and engagementstructure 512 for engaging a drive member 514. Referring first to FIG.29, securing structure 516 is provided for securing the lancet structure506 within the lancet compartment 505. The securing structure 516 allowssome force to be placed on the lancet structure 506 during engagement ofthe drive member 514 therewith without longitudinal displacement of thelancet structure 506. Yet, the securing structure 516 may allow forlongitudinal displacement of the lancet structure 506 in response to aforce above a preselected threshold force.

The securing structure 516 may include spring elements 518 and 520 thatextend outwardly from the extended axis of the lancet structure 506. Thespring elements 518 and 520 may each be received within a respectivenotch 522 and 524, which are sized to receive the spring elements 518and 520. The locking strength of the securing structure 516 can beselected using the spring strength of the spring elements 518 and 520and the exit angle of the notches 522 and 524. In this embodiment, theexit angles of the notches 522 and 524 are less than about 90 degrees.

FIG. 30 illustrates a starting position including the drive member 514with the lancet structure 506 engaged with the securing structure 516.Wing structures 526 and 528 may be provided (FIG. 29) that rest uponsupport structures 530 to space the lancet structure 506 from a reagentmaterial 532. The drive member 514 may be inserted into the lancetcompartment 505 and pushed forwards, in a manner similar to thatdescribed above. In some embodiments, the drive member 514 is subjectedto an upward spring force F (e.g., using a spring), which also is shownby FIG. 31.

In FIG. 31, the drive member 514 includes a guide projection 534 havinga rounded outer periphery and extending upwardly from the hook portion536. The guide projection 534 may engage a downwardly extending camsurface 538 to force the hook portion 536 downward to position the hookportion 536 for engagement with engagement structure 540 of the lancetstructure 506. Referring to FIG. 32, as the guide projection 534 movespast the cam surface 538, the hook portion 536 raises due to the bias Fand engages the engagement structure 540 of the lancet structure 506.

In FIG. 33, the spring elements 518 and 520 (FIG. 29) may free from thenotches 522 and 524 and at FIG. 34, a landing member 542 may engage thecam surface 538 to limit upward movement of the hook portion 536. AtFIGS. 35 and 36, an incision may be made by moving the skin penetratingend 508 through the opening 544 followed by decelerated return movement,in a fashion similar to that described above.

Referring to FIG. 37, at the end of the return movement of the lancetstructure 506, the bias force F acts on the lancet structure 506 therebytensioning the lancet structure 506. With the wing structures 526 and528 (FIG. 29) resting upon support structures 530, a gap remains betweenthe lancet structure 506 and the reagent material 532 as shown by FIG.37. Referring to FIG. 38, with further return movement of the drivemember 514, the wing structures 526 and 528 (FIG. 29) disengage thesupport structures 530 and the skin penetrating end 508 contacts thereagent material 532. The bias force F facilitates contact between theskin penetrating end 508 and the reagent material 532 such that a liquidcontact takes place. Upon further return of the drive member 514, theguide projection 534 engages the cam surface 538 forcing the hookportion 536 to disengage the lancet structure 506 as shown by FIG. 38.Referring to FIG. 39, ribs 544 may be provided to maintain springtension within the lancet structure 506.

FIGS. 40-47 illustrate another embodiment of a lancet housing assembly600 including an upper disk member 602 and a lower disk member 604defining a lancet compartment 605. A lancet structure 606 includes askin penetrating end 608, a blood transfer portion 610 and engagementstructure 612 for engaging a drive member 614. Referring first to FIG.40, an initial position of the lancet structure 606 and the drive member614 is illustrated. In this embodiment, the lancet structure 606includes an outwardly extending spring finger 616 that extends upwardlyat portion 618 and longitudinally at portion 620. A bend 622 connectsthe upwardly extending portion 618 and longitudinally extending portion620. The longitudinally extending portion 620 includes a hump-shapedportion 624 that is received within a notch 626 thereby providingsecuring structure for the lancet structure 606 within the lancetcompartment 605.

The lancet structure 606 includes engagement structure 612 that is usedto engage the lancet structure 606 with a hook portion 630 of the drivemember 614. In the illustrated initial position, the engagementstructure 612 rests on a decline guide ramp or rail 632 that is used tosupport the lancet structure 606 during its extending and retractingphases. The skin penetrating end 608 of the lancet structure 606 restson a support surface 634 at opening 636 through which the skinpenetrating end 608 extends.

Referring to FIG. 41, during a priming and firing sequence, the drivemember 614 enters the lancet compartment 605 and a guide projection 638engages an incline ramp surface 640, which forces the hook portion 630upward as the drive member 614 enters the lancet compartment 605.Referring to FIG. 42, as the drive member 614 continues to move towardthe opening 636, the guide projection 638 engages a decline ramp surface642 and the hook portion 630 travels downward and engages the engagementstructure 612 of the lancet structure 606. Referring to FIG. 43, thehook portion 630 continues to travel down the decline ramp surface 642thereby fully engaging the engagement structure 612 and extending theskin penetrating end 608 of the lancet structure 606 through the opening636. As can be seen by FIGS. 42 and 43, the hump-shaped portion 624 isforced out of the notch 626 by deflecting the spring finger 616 uponapplication of a sufficient force by the drive member 614. The amount offorce needed to release the hump-shaped portion 624 from the notch 626can be selected based on the spring force and the shapes of the notch626 and hump-shaped portion 624. In some embodiments, the hump-shapedportion 624 continues to contact an upper wall surface 644 therebybiasing the lancet structure 606 in a downward direction as the skinpenetrating end 608 is extended. FIG. 44 illustrates the lancetstructure 606 fully extended.

Referring to FIG. 45, during retraction, the skin penetrating end 608 ofthe lancet structure 606 is pulled back into the lancet compartment 605.The pulling force applied by the drive member 614 is sufficient to pullthe hump-shaped portion 624 past the notch 626 to allow the skinpenetrating end 608 to clear the support surface 634 at the opening 636and fall downward toward a reagent material 650 to transfer an amount ofbodily fluid to the reagent material. Unhooking of the engagementstructure 612 occurs as the lancet structure falls toward the reagentmaterial 650 and the guide projection 638 moves up the ramp surface 642.FIGS. 46 and 47 illustrate the lancet structure 606 in its final,released state with the lancet structure 606 in contact with the reagentmaterial 650 and the skin penetrating end 608 offset from the opening636.

The above-described medical diagnostic devices includes a number offeatures that allow for improved comfort and ease of use for a patient.In general, the medical diagnostic devices may include a lancet housingassembly in the form of a cartridge or disk that is used to housemultiple lancet structures for use in the medical diagnostic devices, alancet actuator assembly for extending and retracting the lancetstructures and a speed control mechanism that engages the lancetactuator assembly for adjusting the speed at which the lancet structureis extended and/or retracted by the lancet actuator assembly. A depthadjustment mechanism may also be provided that allows for adjustment ofan initial position of the lancet structure prior to its use, which canadjust the penetration depth of the lancet structure during use.

The above description and drawings are only to be consideredillustrative of exemplary embodiments, which achieve the features andadvantages of the present invention. Modification and substitutions tospecific process steps, system, and setup can be made without departingfrom the spirit and scope of the present invention. Accordingly, theinvention is not to be considered as being limited by the foregoingdescription and drawings, but is only limited by the scope of theappended claims.

What is claimed is:
 1. A lancet housing assembly for use in a portablehandheld medical diagnostic device for sampling bodily fluids from askin site of a patient, the lancet housing assembly comprising: ahousing structure comprising: an outer facing side; an inner facingside; an opening located at the outer facing side that is arranged andconfigured to align with a lancet port of the medical diagnostic device;and a floor that extends between the outer facing side and the innerfacing side; a reagent material located on the floor and within thehousing structure; and a lancet structure located in the housingstructure, the lancet structure comprising a skin penetrating endaligned initially in a first plane with the opening and a bloodtransport portion adjacent the skin penetrating end, wherein the skinpenetrating end is configured to extend in the first plane when extendedthrough the opening and, when extended through the opening, is shapedand sized to penetrate the patient's skin at the skin site to provide anamount of blood, and further is configured to be extended and retractedby a drive member, and a biasing mechanism is configured to force thelancet structure toward the floor when the lancet is retracted to asecond plane parallel to the first plane and offset from the opening,the drive member is configured to pass over the lancet structure whenthe drive member is moved toward the opening and the lancet structure isin the second plane, and the blood transport portion being arranged andconfigured to receive the amount of blood from the skin penetrating endin the second plane and to carry the amount of blood away from the skinsite and to the reagent material.
 2. The lancet housing assembly ofclaim 1, wherein the skin penetrating end of the lancet structure issupported on a bottom surface of the opening at the outer facing sidebefore extending the skin penetrating end through the opening.
 3. Thelancet housing assembly of claim 1, wherein the reagent material isoffset vertically from the opening at the outer face and within thehousing structure.
 4. The lancet housing assembly of claim 1 furthercomprising one or more lancet guide rails that extend along one or moreof sidewalls of the at least one lancet compartment between the outerfacing side and the inner facing side.
 5. The lancet housing assembly ofclaim 4, wherein the lancet structure includes a rail riding structureproviding a support surface that supports the lancet structure upon theone or more lancet guide rails.
 6. The lancet housing assembly of claim5 further comprising one or more drop down slots formed in the one ormore of the sidewalls, the rail riding structure located to align withthe one or more drop down slots such that the skin penetrating end isconfigured to move toward the reagent material when the lancet structureis retracted.
 7. The lancet housing assembly of claim 1 wherein thebiasing mechanism is connected at opposite ends to a ceiling of an upperdisk member of the lancet housing assembly.
 8. A portable handheldmedical diagnostic device for sampling bodily fluids, comprising: aprotective enclosure; a measurement system including a controllerfacilitating a physiologic measurement; a display device connected tothe measurement system that displays information related to thephysiologic measurement; a housing structure comprising: an outer facingside; an inner facing side; an opening located at the outer facing sidethat is arranged and configured to align with a lancet port of themedical diagnostic device; and a floor that extends between the outerfacing side and the inner facing side; a reagent material located on thefloor and within the housing structure; and a lancet structure locatedin the housing structure, the lancet structure comprising a skinpenetrating end aligned initially in a first plane with the opening anda blood transport portion adjacent the skin penetrating end, wherein theskin penetrating end is configured to extend in the first plane whenextended through the opening and, when extended through the opening, isshaped and sized to penetrate the patient's skin at the skin site toprovide an amount of blood, and further is configured to be extended andretracted by a drive member, and a biasing mechanism is configured toforce the lancet structure toward the floor when the lancet is retractedto a second plane parallel to the first plane and offset from theopening, the drive member is configured to pass over the lancetstructure when the drive member is moved toward the opening and thelancet structure is in the second plane, and the blood transport portionbeing arranged and configured to receive the amount of blood from theskin penetrating end in the second plane and to carry the amount ofblood away from the skin site and to the reagent material.
 9. Themedical diagnostic device of claim 8, wherein the skin penetrating endof the lancet structure is supported on a bottom surface of the openingat the outer facing side before extending the lancet structure.
 10. Themedical diagnostic device of claim 8, wherein the reagent material isoffset vertically from the opening at the outer face and within thehousing structure.
 11. The medical diagnostic device of claim 8 furthercomprising one or more lancet guide rails that extend along one or moreof the sidewalls between the outer facing side and the inner facingside.
 12. The medical diagnostic device of claim 11, wherein the lancetstructure includes a rail riding structure providing a support surfacethat supports the lancet structure upon the one or more lancet guiderails before extending the lancet structure.
 13. The medical diagnosticdevice of claim 12 further comprising one or more drop down slots formedin the one or more of the sidewalls, the rail riding structure locatedto align with the one or more drop down slots such that the skinpenetrating end is configured to move toward the reagent material. 15.The medical diagnostic device of claim 8 further comprising a motoroperatively connected to the lancet structure.
 16. A method ofcontrolling movement of a lancet structure provided within a lancethousing assembly in a portable handheld medical diagnostic device forsampling bodily fluids from a skin site of a patient, the methodcomprising: providing a lancet structure located the lancet housingassembly, wherein the lancet housing assembly is configured to have anouter facing side and an opening located at the outer facing side thatis arranged and configured to align with a lancet port of the medicaldiagnostic device, the lancet structure comprising a skin penetratingend aligned initially in a first plane with the opening and a bloodtransport portion adjacent the skin penetrating end, wherein the skinpenetrating end is configured to extend in the first plane when extendedthrough the opening and, when extended through the opening, is shapedand sized to penetrate the patient's skin at the skin site to provide anamount of blood, and further is configured to be extended and retractedby a drive member, and a biasing mechanism is configured to force thelancet structure toward a lancet floor when the lancet is retracted to asecond plane parallel to the first plane and offset from the opening,the drive member is configured to pass over the lancet structure whenthe drive member is moved toward the opening and the lancet structure isin the second plane, and the blood transport portion being arranged andconfigured to receive the amount of blood from the skin penetrating endin the second plane and to carry the amount of blood away from the skinsite and to a reagent material located on the floor within the at leastone lancet compartment; extending the skin penetrating end through aport of the medical diagnostic device and penetrating the patient's skinat the skin site to provide an amount of blood; receiving the amount ofblood at the skin penetrating end; and carrying the amount of blood awayfrom the skin site to the reagent material using the blood transportportion.
 17. The method of claim 16 comprising supporting the skinpenetrating end of the lancet structure on a bottom surface at the portwith the lancet structure before extending the skin penetrating end. 18.The method of claim 16 further comprising providing a reagent materialoffset vertically from the port within the lancet compartment.
 19. Themethod of claim 16 further comprising connecting a motor to the lancetstructure.